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NCT00867269 · ClinicalTrials.gov registry record

Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia

A clinical trial of Warts and Cryptococcal Meningitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
950
Enrollment target
1
Study location

NCT00867269 is a study of Warts and Cryptococcal Meningitis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 950 participants, above the 86-participant average among 7 other Warts trials with a reported enrollment target (1005% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00867269, a study of Warts and Cryptococcal Meningitis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
950 participants
Enrollment target
1
Study location

Study Summary

Background: * Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic infections or autoimmune disorders and diseases. Objectives: * To characterize the natural history with regard to CD4+ T cell count and onset of infection, malignancy, and autoimmunity. * To describe the immunological status of patients affected by ICL while providing the best possible standard therapy to eradicate opportunistic infections. * To establish the timeline of CD4 lymphocytopenia, with particular focus on defining subgroups of patients according to the decline, stabilization, or rise of CD4+ T cell counts over time. * To characterize the opportunistic infections that occur in ICL patients at microbiologic and molecular levels. * To characterize the immunophenotype and possible genetic immunodeficiency causes of ICL. * To determine whether measurable immunologic parameters correlate with the development of opportunistic infections or other comorbidities such as lymphoma in patients with ICL. * To determine whether there is any association between ICL and autoimmunity. * To determine CD4+ T cell turnover, survival, functionality, and cytokine responsiveness in ICL patients. Eligibility: * Patients 2 years of age and older with an absolute CD4 count less than 300 in children 6 years or older and adults or less than 20% of T cells in children younger than 6 on two occasions at least 6 weeks apart. * Patients with negative results of HIV testing by ELISA, Western Blot, and viral load. * Patients must not have underlying immunodeficiency conditions, be receiving cytotoxic chemotherapy (anti-cancer drugs that kill cells), or have cancer. Design: * At the initial visit to the National Institutes of Health, the following evaluations will be conducted: * Personal and family medical histories. * Physical examination, including rheumatology evaluation and other consultations as

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 950 participants
Start Date 2009-07-13

What the Registry Record Tells You About NCT00867269

The ClinicalTrials.gov registry entry for NCT00867269 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 950 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 7 other Warts trials with a reported enrollment target (1005% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Warts appearing as the primary indexed condition, and to 0 interventions.

NCT00867269 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00867269 about?

NCT00867269 is a clinical study titled "Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia". Background: * Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic infections or autoimmune disorders and diseases. Objectives: * To characterize the natural history with regard t...

What is the current status of trial NCT00867269?

This trial is currently recruiting. The enrollment target is 950 participants. The study started on 2009-07-13.

What conditions does trial NCT00867269 study?

This clinical trial studies the following conditions: Warts, Cryptococcal Meningitis, Idiopathic CD4+ Lymphocytopenia.

Who is sponsoring clinical trial NCT00867269?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00867269 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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